FDA (Devices) recall action 91134
The FDA (Devices) publishes a recall like this one as 156 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 156 pages.
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DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
DeRoyal Industries is recalling 480 myelogram procedure packs because they contain 3M Steri Drapes that have been recalled. These packs were distributed to medical facilities in 23 states.
DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
DeRoyal has voluntarily recalled 117 TRACECART shoulder arthroscopy kits distributed across 23 U.S. states. No illnesses or injuries have been reported. The specific reason for the recall is not disclosed in available FDA documentation.
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.
DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.
DeRoyal Industries is recalling 48 kits of EYE TRAY procedure packs that contain 3M Health Care Steri Drapes which have been recalled.
DeRoyal Industries initiated a voluntary recall of 715 Lapinectomy Pack surgical kits (Ref 89-7198.11) distributed to 23 US states. The FDA Class II recall remains ongoing.
DeRoyal Industries Inc recalled 16 kits of DeRoyal TOTAL HIP PACK (Lot 56042728, expiring May 1, 2026) distributed across 23 U.S. states. The specific reason for the recall was not provided in available agency documentation.
DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.
DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available documentation.
DeRoyal Industries is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
DeRoyal Industries initiated a voluntary recall of the DeRoyal EMERGENT TRAUMA PACK (6 kits). The recall affects units distributed across 23 U.S. states.
DeRoyal Industries is recalling GEO-MED KNEE ARTHROSCOPY PACK units containing 3M Health Care Steri Drapes due to a supplier recall. No reported illnesses or injuries.
DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.
DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.
DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.